Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B

Jourdain, Gonzague; Ngo‐Giang‐Huong, Nicole; Harrison, Linda; Decker, Luc; Khamduang, Woottichai; Tierney, Camlin; Salvadori, Nicolas; Cressey, Tim R.; Sirirungsi, Wasna; Achalapong, Jullapong; Yuthavisuthi, Prapap; Kanjanavikai, Prateep; Ayudhaya, Orada Patamasingh Na; Siriwachirachai, Thitiporn; Prommas, Sinart; Sabsanong, Prapan; Limtrakul, Aram; Varadisai, Supang; Putiyanun, Chaiwat; Suriyachai, Pornnapa; Liampongsabuddhi, Prateung; Sangsawang, Suraphan; Matanasarawut, Wanmanee; Buranabanjasatean, Sudanee; Puernngooluerm, Pichit; Bowonwatanuwong, Chureeratana; Puthanakit, Thanyawee; Klinbuayaem, Virat; Thongsawat, Satawat; Thanprasertsuk, Sombat; Siberry, George K.; Watts, D. Heather; Chakhtoura, Nahida; Murphy, Trudy V.; Nelson, Noele P.; Chung, Raymond T.; Pol, Stanislas; Chotivanich, Nantasak

doi:10.1056/nejmoa1708131

Cited by 241 publications

(293 citation statements)

References 28 publications

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“…The target maternal HBV DNA level at delivery is theoretically as low as possible because of high correlation between MTCT rate and maternal viral loads. Practically, maternal HBV DNA less than 5.0 to 6.0 log 10 IU/mL is considered an anticipated level with minimal risk of MTCT at delivery and the same prior to amniocentesis because MTCT was absent when maternal HBV DNA was less than 7.0 log 10 IU/mL in previous and our studies. Therefore, it is feasible to give at least 4 weeks of antiviral treatment to highly viremic mothers and to achieve an aforementioned target HBV DNA level before amniocentesis.…”

Section: Discussionmentioning

confidence: 48%

“…Although this trend of decreasing MTCT rates in highly viremic mothers (from 14.29% to 0%) was not statistically significant (possibly explained by the small number of cases), it still suggests that antiviral therapy should be effective for preventing HBV transmission after amniocentesis in mothers with high viral loads. However, it is difficult to determine the ideal treatment regimen considering the optimal time of initiation, appropriate duration, and target maternal HBV DNA level at delivery of antiviral therapy because of heterogeneous study design . To prevent MTCT, some professional societies recommended short‐term maternal antiviral treatment starting from the late second or third trimester up to 0 to 12 weeks after delivery with the threshold of maternal HBV DNA more than 5.0 to 8.0 log 10 IU/mL.…”

Section: Discussionmentioning

confidence: 99%

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Mother‐to‐child transmission of hepatitis B virus after amniocentesis: A retrospective matched cohort study

et al. 2019

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Objective The objective of this study is to determine whether amniocentesis increases the risk of mother‐to‐child transmission (MTCT) of hepatitis B virus (HBV) and evaluate risk factors for MTCT. Methods One hundred forty‐three hepatitis B surface antigen (HBsAg)–positive women with amniocentesis were enrolled into the amniocentesis group. Six hundred five nonamniocentesis cases were matched with amniocentesis cases based on maternal viral loads, antiviral therapy regimens, and delivery dates. MTCT of HBV was defined as HBsAg and/or DNA positivity in infants from birth to age 7 to 12 months. Results Mother‐to‐child transmission rate was significantly higher in HBsAg‐positive women with amniocentesis than in those without amniocentesis (2.80% vs 0.50%; relative risk [RR], 5.64; 95% CI, 1.28‐24.93). In the amniocentesis group, maternal HBV DNA more than or equal to 7.0 log10 IU/mL and hepatitis B e‐antigen (HBeAg) positivity were associated with higher MTCT rates than maternal HBV DNA less than 7.0 log10 IU/mL (10.81% vs 0%, p = .004) and HBeAg negativity (8.16% vs 0%, p = .013), and antiviral therapy reduced MTCT rate from 14.3% to 0% (p = .554) when maternal HBV DNA was more than or equal to 7.0 log10 IU/mL. Conclusions Amniocentesis increases the risk of MTCT in women with hepatitis B, and maternal HBV DNA more than or equal to 7.0 log10 IU/mL and HBeAg positivity are risk factors for MTCT. Antiviral therapy may be effective to prevent MTCT after amniocentesis in highly viremic mothers.

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Section: Discussionmentioning

confidence: 48%

Section: Discussionmentioning

confidence: 99%

Mother‐to‐child transmission of hepatitis B virus after amniocentesis: A retrospective matched cohort study

et al. 2019

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“…The information about HBsAg, HBV DNA, length, weight and malformation was collected for further comparisons. Of the 32 RCTs that enrolled 4189 pregnant women, 17 studies evaluated the effect of LAM, 15 studies evaluated LdT, 3 studies evaluated TDF, and 3 studies evaluated both LAM and LdT . Of the 27 non‐RCT studies enrolling 5039 pregnant women, 10 evaluated LAM, 18 evaluated LdT, 3 studies evaluated TDF, 2 evaluated both LAM and LdT, and another 2 studies evaluated both LAM and TDF .…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of antiviral treatment on blocking the mother‐to‐child transmission of hepatitis B virus: A meta‐analysis

Song

Yang

Wang

et al. 2018

Journal of Viral Hepatitis

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Summary Nucleo(t)side analogues (NAs) have been administered as adjunctive therapy to interrupt the mother‐to‐child transmission (MTCT) of hepatitis B virus (HBV). The efficacy and safety of this method remain controversial. A meta‐analysis was conducted to evaluate the efficacy and safety of NAs treatment during pregnancy. The differences among different agents and initiation trimesters were analysed. A total of 9228 mother‐infant pairs in 59 studies (32 RCTs and 27 non‐RCTs) were included in this meta‐analysis. NAs significantly reduced the risk of MTCT, as indicated by seropositivity of hepatitis B surface antigen (HBsAg) (risk ratio (RR) = 0.51, 95% confidence interval (CI) 0.45‐0.57) and HBV DNA in newborns (RR = 0.22, 95% CI 0.18‐0.26). No differences in the efficacy of interrupting HBV MTCT were evident among lamivudine, telbivudine and tenofovir disoproxil fumarate. NA was more effective when administered from the second than from the third trimester as indicated by HBV DNA (RR: the second vs the third 0.08 vs 0.22, P = 0.010), but this effect was not evident as indicated by HBsAg (RR: the second vs the third 0.46 vs 0.53, P = 0.596). Antiviral treatment initiated from the second trimester did not confer a higher risk of safety problems in the newborns compared with treatment from the third trimester, as indicated by weight (P = 0.064), length (P = 0.491) and malformation rate (P = 0.635) of newborns. Conclusions Lamivudine, telbivudine and tenofovir disoproxil fumarate are equally effective in blocking HBV MTCT. Antiviral treatment can be applied from the second trimester, without obvious safety concerns.

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“…As underlined in the WHO guidelines for the management of chronic hepatitis B and recent Lancet commission, there is an urgent need for more research into HBV MTCT, particularly in the African region. Currently, strategies for the prevention of HBV MTCT are mainly built on data from Asian and Western studies . In some countries in the African region, the prevalence of HBsAg amongst pregnant women has been documented, although in the absence of a national antenatal screening programme for HBV, these data are often not nationally representative.…”

Section: What Remains To Be Done?mentioning

confidence: 99%

Mother‐to‐child transmission of hepatitis B: What more needs to be done to eliminate it around the world?

Nayagam

Shimakawa

Lemoine

2020

Journal of Viral Hepatitis

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Mother‐to‐child transmission (MTCT) of hepatitis B virus (HBV) is a key component of the hepatitis B burden worldwide. Despite its efficacy to prevent HBV transmission, infant vaccination is not enough to control HBV MTCT. Additional efforts are urgently needed to evaluate and scale‐up preventive strategies especially in endemic countries, which are most affected. This review highlights the efficacy and barriers of the currently validated measures for the prevention of HBV MTCT and proposes alternatives adapted to resource‐limited settings to eventually achieve HBV elimination worldwide.

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Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B

Cited by 241 publications

References 28 publications

Mother‐to‐child transmission of hepatitis B virus after amniocentesis: A retrospective matched cohort study

Mother‐to‐child transmission of hepatitis B virus after amniocentesis: A retrospective matched cohort study

Efficacy and safety of antiviral treatment on blocking the mother‐to‐child transmission of hepatitis B virus: A meta‐analysis

Mother‐to‐child transmission of hepatitis B: What more needs to be done to eliminate it around the world?

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